Reported Feb 20, 2019 · Ongoing
Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
- Medtronic implantable pulse generatorSphera DR MRI SureScan, Dual chamber
- rate responsive pacemaker (DDDR)(a) Model Number SPDR01 (b) Model Number SPDRL1
- Lot codes and dates
- Sphera DR MRI SureScan, Dual chamber
- rate responsive pacemaker (DDDR)
(a) Model Number SPDR01GTIN 0064316988295900763000109097All Serial Numbers (b) Model Number SPDRL1GTIN 0064316988296600763000109103All Serial Numbers
- Amount recalled
- 5392 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Why it was recalled
Stop using this product now
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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